Disposable Cartridge, Apparatus and System for the Blood Treatment

ABSTRACT

The invention relates to a disposable cartridge usable for a blood treatment apparatus provided with at least one frontal access pump; the cartridge consists of at least one duct portion whose structure and position, by approaching the disposable cartridge to the apparatus, determine the association of said duct portion with said pump, so as to complete the apparatus in order to use it.

The present invention relates to a disposable cartridge or module, an apparatus and a system for blood treatment.

The present invention is suitable for being used in a medical/hospital field and, in particular, it relates to the problem of the setting of the machines used for dialysis, haemofiltration, decapneization or blood oxygenation and, generally speaking, for all the apparatus which comprise one or more peristaltic pumps and/or syringe pumps and which need complicated operations for placing the underpump tubes in their correct operating positions, for placing in their holders blood filters, oxygenators and other circuit components connected to one another by means of a complex flexible tube connection network, drip caps, devices for eliminating blood blisters, pressure sensors, temperature sensors, heaters and so on.

One of the aims of the present invention is simplifying the functioning and the start of well known procedures in a shorter time, limiting the risk of assembly mistakes; moreover, it is possible to limit the need of highly qualified personnel and to obtain advantages such as a reduction of the priming volume thanks to the optimization and to the shortness of connections and to use rigid connection tubes without toxic plasticizers (phthalates) which are more biocompatible in general, as well to obtain a reduced hemolysis due to the functioning of the peristaltic pump; said pump, as will be described, allows a much more linear and homogeneous exit flux than in current peristaltic devices as well as an extremely reduced hemolysis. Therefore, the aim of the present invention is eliminating the above mentioned inconveniences.

According to the invention, these results have been achieved by adopting the idea of a disposable cartridge, an apparatus and a system for the blood treatment having the features described in the independent claims. Further features are the subject of the dependent claims.

One of the advantages of the present invention is that the preparation procedures and the starting of the apparatus for blood treatment are remarkably simplified; the risk of mistakes is basically eliminated; this apparatus can be used by personnel which is not highly qualified and the priming is remarkably reduced; it offers a system consisting of a disposable cartridge characterized by a high biocompatibility and a reduced hemolysis Each technician who works in this field will understand these advantages and further advantages of the present invention thanks to the following description and to the enclosed drawings as a practical exemplification of the invention, which should not be considered in a limitative sense, wherein:

FIG. 1 shows a possible embodiment of an appliance for blood treatment according to the present invention, schematically shown in a front view;

FIG. 2 shows a possible embodiment of a disposable cartridge or module according to the present invention, schematically shown and in a partial front view;

FIG. 3 is a schematic section view of the appliance of FIG. 1 placed in front of the disposable cartridge of FIG. 2, with the cartridge shown in a more complete configuration, that is provided with more components than that in FIG. 2;

FIG. 4 shows the view in FIG. 1, in which some components of the disposable cartridge of FIG. 2 have schematically been associated with the apparatus;

FIG. 5 is an enlarged schematic lateral view of the pump according to the present invention shown in FIG. 3;

FIG. 6 is a schematic lateral view of another embodiment of a pump according to the present invention;

FIG. 7 is the scheme of an alternative embodiment of a frontal access peristaltic pump;

FIG. 8 is the scheme of a possible embodiment of ducts according to the present invention;

FIG. 9 schematically shows the positioning of a couple of pumps acting on a split tube portion;

FIG. 10 is a schematic front view of a further embodiment of a pump according to the present invention;

FIG. 11 is a schematic lateral view of the example of FIG. 10;

FIG. 12 is a schematic front view of a further embodiment of a pump according to the invention, shown in a maximum extension configuration;

FIG. 13 shows the pump of FIG. 12 in a minimum extension configuration.

A possible example of a system consisting of an apparatus and of a disposable cartridge or module according to the invention is described in the following, with an initial reference to FIGS. 1-6;

The term module or cartridge used in the present description refers to a disposable container 1 with at least one rigid wall or portion 2 which contains: the components necessary for the treatment procedure and for the corresponding internal connections; pre-positioned connections or connections which are assembled with those external to the patient as well as for any sub-containers for waste products to be eliminated; the mechanical support of the under-pump tubes (understood as a reaction plane of the frontal access peristaltic pumps contained in the base apparatus for blood treatment). All the internal components of the disposable cartridge and the external connections are preassembled, so as to be ready for use.

In particular, the disposable cartridge 1 which can be made of transparent and rigid plastic material, is provided with fixing means for apparatus 3 (also called base 3 in the present description) which allow an operating connection capable of exchanging data with the temperature and pressure sensors, with air bubble detectors, blood blisters detectors and so on, but also of allowing the liquids contained or passing through disposable cartridge 1 to be moved by means of a system of “frontal access peristaltic pumps” which do not require a manual operation for their preparation and can function as soon as they are connected to cartridge 1.

Cartridge 1 can be provided with an identification element which allows a given cartridge to be associated with a corresponding treatment procedure. For example, disposable cartridge 1 can be provided with an identification element which allows the association of a given cartridge with a corresponding treatment procedure. For example, disposable cartridge 1 can be provided with a chip or with a similar device interacting with a corresponding reader placed on base 3. The reader placed on base 3 can emit a corresponding consensus or error signal and, if necessary, indicate, for example in a screen, the parameters of the treatment to be executed. This allows a further reduction of possible errors when preparing the appliance for blood treatment. In FIG. 2 the identification element on disposable cartridge 1 is schematically represented by a rectangle 80, while rectangle 81 of FIG. 1 represents the reader of base 3. Identification element 80 and corresponding reader 81 can be replaced with particular structures of the disposable cartridge and of the base, which allow the coupling of the two parts of the blood treatment system. For example it is possible to provide a male-female association with a particular shape and/or dimensions of the elements which fit with one another so that the base can recognise the cartridge suitable for the foreseen treatment which has been set.

In the non limitative example shown in the figures, base 3 is provided with three front access peristaltic pumps 31, 32, 33. Three corresponding tube portions 11, 12, 13 are present on disposable cartridge 1 which are in contact with said pumps 31, 32, 33, when disposable cartridge 1 is associated with base 3. In practice, in the non-limitative example shown in the drawings, disposable cartridge 1 features on one side (in the example the side with a greater surface) some tube segments 11, 12, 13 projecting from disposable cartridge 1. These tube segments are positioned adjacent to the disposable cartridge itself.

Some pressure or temperature transducers or transducers for other values to be measured, as well as other tube segments 16, 17 on which some clamps act, oxygen connectors or similar devices can be positioned near these tubes. According to the type of therapy to be carried out, disposable cartridge 1 is duly provided with suitable components such as filtering devices, measurers and so on. These devices are already well known and will not be described in detail. The transducers may consist of membranes acting on corresponding detectors positioned on the base, which are capable of exchanging data with the detectors. In practice, the membranes can define a physical connection (pneumatic or hydraulic) with the corresponding internal detector on the base.

With reference to the example illustrated, disposable cartridge 1 is provided with a filtering device for blood or haemofilter 21, with an hoxygenator device or decapneizator 22, with an oxygen connector 28 featuring a corresponding delivering device 38 positioned on base 3, as well as with two ducts 24 and 25 which allow the entry and exit connection with the patient under treatment according to a well known method. Once the disposable cartridge suitable for the therapy to be carried out has been chosen, by applying disposable cartridge 1 to appliance 3, frontal access pumps 31, 32, 33 contained in the apparatus will be coupled to tube segments 11, 12, 13 containing the liquids to be moved which are part of disposable cartridge 1; at the same time, pressure transducers 15 will be in contact with corresponding detectors 35 on base 3, the oxygen connector 28 will be coupled to the opening 38 of the delivering device, the “clamp” 39 of base 3 will be positioned in contact with tube segment 16 which is to be occluded, bubble and blood blister detectors will be positioned on the tube segment adjacent to it (the example schematically shows an air bubble detector acting on tube portion 16 and a blood blister detector 37 acting on tube portion 17) and the apparatus for filtering and removing carbon dioxide, at this point, after carrying out up the only connection of the disposable cartridge, can be started.

The apparatus or base is usually provided with a screen, which displays the possible procedures according to the disposable cartridge actually assembled, the parameters set, the correct functioning of the disposable cartridge, possible alarms and the possibility for the operator to vary the above parameters. It is possible to add accessories such as printers, connections to the network and so on. In FIG. 1, numerical reference 86 shows the adjustment means for the oxygen flow.

Disposable cartridge 1 can contain the components for measuring the different values, the connection tubes, the “active” components such as haemo-concentrators, oxygenators, haemofilters, dyalisis filters, possible control components such as droppers, de-bubblers, sub-containers to be filled with drugs (for example heparin).

With reference to the example of FIG. 8, to obtain a further reduction of the priming volume and to render connections (ducts) more linear, some of the connections can be made by performing a passage between two correspondingly grooved plates of suitable material which are then glued to each other so as to form a circuit inside a “plate” for taking all the various liquids to the various components (internal or external components) like copper tracks in an electronic circuit. The schematic view of FIG. 8, numerical reference 5 indicates two associated plates which form two ducts 6.

As said above, frontal access peristaltic pumps allow the liquids to be moved through the tubes they are in contact with, without the action of the operator necessary in traditional pumps.

The example of FIGS. 1-6 shows peristaltic pumps 31, 32, 33 in which the so called “rotor” which presses on the tube, does not act against a surface which is part of the pump and in a radial direction in relation to the rotor itself, but it acts frontally (like a front cam) against the tube and against a rigid matching surface 2 which is part of disposable cartridge 1. In practice, each of pumps 31, 32, 33 is provided with a plurality of hammer elements 300, 301 placed along the longitudinal development of tube portions 11, 12, 13 and sequentially moved to engage the corresponding points of the tube portions, so as to obtain a peristaltic effect.

In particular, for a better description of the functioning, FIG. 5 shows a linear pump (indicated with 30 and shown also in FIG. 3), which is provided with three hammer elements 300, 301. Pump 30 comprises a cam shaft 302 and three hammer elements 300, 301 with suitable dimensions which are placed side by side, that is to say they are overlapped when the pump is in a vertical position like in FIG. 3. In particular, the three hammer elements consist of a central element 300 which is longer, and of two lateral elements 301 which are shorter, one of which is placed upstream, while the other is placed downstream to element 300. The cam shaft features three different suitably shaped cams so as to internally detect hammer elements 300, 301 and to push them toward tube portion 12 or to move it away from it. In practice, cam shaft 302 (on which hammer elements 300, 301 are fitted) can be rotated by acting on one of its ends 303 by means of motor means (consisting of motor 304 connected to shaft 302 by means of belt 305) so as to sequentially push the three hammer elements 300, 301 against tube portion 12. Hammer elements 300, 301 suitably compress the tube portions of disposable cartridge 1 thanks to the presence of the rigid wall 2 which acts as an “anvil” or reaction plane for the hammer elements and which is part of disposable cartridge 1. In fact, central element 300, which is much longer than lateral elements 301 acts as real a pumping element while the two external elements 301 act as valves; in practice external elements 301 completely compress the tube so as to occlude it, while central element 300 crushes the tube only until a percentage value of nearly 90% without damaging the solid components of blood (especially erytrocytes) and reducing hemolysis in comparison with traditional peristaltic pumps.

In an alternative embodiment shown in FIG. 6, the two external pump hammer elements are replaced with non return valves 310 (for example sphere valves) positioned at the beginning and at the end of the portion of under-pump tube 12; in this case the pump consists of a single hammer element 300.

FIG. 9 schematically shows a further embodiment of the invention, which consists of two pumps 30 and 30′ acting on the portion of a split tube, that is a tube 12 which is split into two ducts 120 and 120′ in one of its intermediate sections, which ducts, upstream and downstream to the area on which the pumps act, are joined again, so as to reform said tube 12. The two pumps 30 and 30′ are reverse-phase operated so that their hammer elements 300, 301, 301′ alternatively interact with corresponding tube portions 120 and 120′. In particular, pump 30 comprises a central hammer element 300 and the lateral elements 301′; correspondingly, pump 30′ comprises a central hammer element 300′ and the lateral elements 301′. In this way, instead of an intermittent pulsing action, it is possible to obtain a substantially continuous flux, in which the instantaneous flow is similar to the medium flux, so that it is possible to maintain the pressure values which the filters or other components can bear, in order to avoid damages due to a possible pressure peak or coagulations which can cause clots or other problems.

The examples of FIGS. 1-6 show the use of frontal access peristaltic pumps which develop linearly and are provided with hammer elements. According to the present invention, the pump can be “rotary” or “linear” depending on the fact that the pressure the pump exerts on the tube, so as to obtain a peristaltic effect, acts either on an arc of circumference or on a segment of a straight line (like in the example shown).

FIG. 7, instead, shows a frontal access peristaltic pump 130 which is not provided with the hammer elements described above but with a basically traditional rotor 131 acting on walls 132 presented by the pumps itself 130 so as to press, by means of two ends 135, a tube 133, schematically shown with dashed lines. Ends 135 can consist of rolls whose axis is parallel to rotation axis C of the body of rotor 131. In the usual way, the rotation (see arrow R) performed by rotor 131 determines the peristaltic effect which pushes the fluid contained in duct 133. In this embodiment, walls 132 are advantageously presented by two half bodies 134 which can be approached to each other or moved away from each other as indicated by arrows F. In order to allow a correct coupling to pump 130, the disposable cartridge is provided with a tube portion whose development allows its introduction between the ends 135 of rotor 131 and the walls 132, when the two half bodies 134 are far from each other. With reference to the example shown, the tube portion to be fixed to the disposable cartridge features a basically annular development, which is open at the bottom, with two arms extending downwards so as to fit the profile of walls 132. In other terms, said portion ca be 'Ω shaped (omega). The tube portion projects from the corresponding face of disposable cartridge so that it can be inserted around rotor 151 by simply approaching the disposable cartridge to the base. In practice, when preparing the apparatus for blood treatment, half bodies 134 are placed away from each other and kept in this position until tube 133 is inserted around rotor 131; then, half bodies 134 are joined to each other so that walls 132 compress the tube at ends 135 of rotor 131. Once rotor 131 has been operated, the peristaltic pressure of the liquid contained in tube 133 starts.

An alternative of said rotary peristaltic pump is schematically shown in FIGS. 12 and 13. In this case, rotor 131 consists of two arms 131 a and 131 b and it is capable of becoming “compact” (see FIG. 13) (for example telescope-like or pantograph-like) by reducing the extension of its arms 131 a and 131 b so as to allow the introduction of the under-pump tube and by keeping a fixed position of the wall (schematically shown by area 132′ in the figures). Rotor 131 is capable of returning to its extended operating position (see FIG. 12) when the tube is in the correct position and the disposable cartridge is completely inserted on the base. Even in this case, the tube portion presented by disposable cartridge 1 can be basically “'Ω” shaped.

The disposable cartridge which can be used for the examples of FIGS. 7, 12 and 13 can obviously be provided with the same components as those shown in the examples of FIGS. 1-6 in addition to a tube portion whose shape allows its positioning around the rotor. In other words, by simply bringing the disposable cartridge nearer to the apparatus, the latter will be ready for treatment.

FIGS. 10 and 11 schematically and partially show an embodiment of a frontal access peristaltic pump 30. The pump shown in FIGS. 10 and 11 consists of a rotor 131′ capable of rotating around a corresponding axis C, which, in the example, coincides with shaft 230 of a motor 231 determining the rotation of rotor 131′. Rotor 131′ consists of two arms 131 c and 131 d whose axes A are orthogonal to rotation axis C of the rotor, in a radial position. Rotor 131′ is provided with two pressure elements 135′ consisting of rotary cylinders whose axis coincides with axis A of arms 131 c and 131 d; in practice cylinders 135′ can rotate around an axis which is radially positioned in relation to rotor 131′ so as to interact on the front, that is to say with its cylindrical surface with tube portions presented by cartridge 1 which is coupled to a base 3 which presents said pump 30.

Tube portion 12, which is schematically shown with dashed lines in FIG. 10, obviously features an open-ring structure, that is according to an arc of circumference.

In this last embodiment, pump 30 is a rotary pump and the pressure elements are not the hammers 300, 301 described above with reference to the examples of FIGS. 1-6 and 9, but the two rotary cylinders featuring rotation axis (A) along the radiuses of the rotor and acting as a rotary frontal cam on tube 12. Even in this case, disposable cartridge 1, in addition to tube portion 12 shown in the figure, is provided with other components which are not shown in FIGS. 10 and 11 in order to simplify their explanation.

The basic concept of the present invention is that of manufacturing a frontal access pump which can be coupled to a disposable cartridge, in which the position and the structure of the various active and passive components allows their direct coupling to the corresponding parts of the base apparatus. So, the base apparatus can be provided with one or more frontal access peristaltic pumps, with pressure elements which can be coupled to one or more tube portions presented by the disposable cartridge, as said pumps can be “rotary” or “linear” pumps as specified above. In the same way, the base apparatus can be provided with one or more frontal access peristaltic pumps provided with a rotor and mobile walls, (or with a “collapsable” rotor) which can be coupled with one or more corresponding tube portions whose structure allows their positioning around the rotor when the disposable cartridge is couple to the apparatus.

In all the above non limitative cases the apparatus and the disposable cartridge can be provided with additional pumps, ducts, measuring and filtering devices, oxygenators and so on, whose structure allows the immediate starting of the apparatus without the complex preparation procedures of the well known technique.

The control devices of the elements described above, which are shown in the enclosed drawings, are known to the technicians who work in this field and, for this, reason, they have not been described in detail in order to simplify their explanation. Moreover, the execution details may vary as regards the shape the size, the arrangement of the elements, the kind of material used, but they are within the limits of the solution adopted and within the limits of the protection offered by the present patent. 

1-16. (canceled)
 17. A disposable cartridge for a blood treatment apparatus having at least one frontal access pump, said disposable cartridge comprising: at least one tube portion whose structure and position, by approaching said disposable cartridge to the apparatus, determine an association of said tube portion with the pump, so as to complete the blood treatment apparatus in order to use the apparatus, wherein: the frontal access pump is provided with at least one hammer element, and said disposable cartridge further comprises at least one mechanically rigid wall which defines a reaction plane for the at least one hammer element.
 18. The disposable cartridge of claim 17, wherein the frontal access pump is provided with a plurality of hammer elements positioned along a rectilinear stretch, and a corresponding tube portion, fixed to said disposable cartridge and on which the hammer elements act, extends linearly.
 19. The disposable cartridge of claim 17, wherein said tube portion on which the pump acts comprises two valve elements positioned respectively downstream and upstream from an action area of the at least one hammer element.
 20. The disposable cartridge of claim 17, wherein said disposable cartridge further comprises a plurality of components necessary for a blood treatment procedure and corresponding internal connections.
 21. The disposable cartridge of claim 17, further comprising an identification element adapted to be univocally associated with a corresponding identification element of the blood treatment apparatus.
 22. The disposable cartridge of claim 17, wherein said at least one tube portion comprises at least one duct formed by a coupling of two plates, at least one of which being grooved.
 23. An apparatus for blood treatment adapted to be equipped with a disposable cartridge, said apparatus comprising: at least one frontal access peristaltic pump adapted to interact with a corresponding tube portion presented by the disposable cartridge, wherein said at least one pump comprises at least one hammer element adapted to interact with at least one tube portion presented by the disposable cartridge, the disposable cartridge being provided with at least one mechanically rigid wall which defines a reaction plane for said at least one hammer element.
 24. The apparatus of claim 23, further comprising a cam element which moves said at least one hammer element.
 25. The apparatus of claim 23, wherein said at least one pump is adapted to push said at least one hammer element against the at least one tube portion in order to compress the at least one tube portion, and a stroke performed by said at least one hammer element does not completely crush the at least one tube portion.
 26. The apparatus of claim 23, wherein said pump further comprises two additional hammer elements which are positioned respectively downstream and upstream of said at least one hammer element.
 27. The apparatus of claim 27, further comprising: a rotor; and at least one mobile wall which defines a reaction surface for said rotor, said at least one mobile wall being adapted to move so as to allow the introduction of the at least one tube portion presented by the disposable cartridge between said rotor and said at least one wall when the disposable cartridge approaches said apparatus.
 28. A blood treatment system comprising: an apparatus for blood treatment having at least one frontal access peristaltic pump; and a disposable cartridge in which active components, passive components, and connection components are positioned and structured in such a way as to be coupled directly to corresponding parts of said apparatus when said disposable cartridge approaches said apparatus, wherein said frontal access pump comprises at least one hammer element and said disposable cartridge comprises at least on mechanically rigid wall which defines a reaction plane for said at least one hammer element. 